Status:
UNKNOWN
Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)
Lead Sponsor:
Before Brands, Inc
Collaborating Sponsors:
Duke Clinical Research Institute
Conditions:
Diet Diversity
Infant Nutrition
Eligibility:
All Genders
4-6 years
Phase:
NA
Brief Summary
This is a randomized, controlled, open-label, pragmatic, direct-to-participant trial designed for infants. The study will be conducted using a mobile application platform to engage parents with health...
Eligibility Criteria
Inclusion
- Male or female 4-6 months of age at time of consent
- Provision of signed and dated informed consent form parent/guardian(s)
- Parent/guardian(s) stated willingness to introduce within 12 months and feed the participant 5 common foods, including peanuts, cashew, egg, sesame, and cod
- In good general health as evidenced by medical history reported by the parent/guardian(s)
- No known allergy to any of the ingredients in the study intervention (SO), their components, or excipients
Exclusion
- Known physician confirmed allergies to any of the ingredients in SO at the time of consent
- Gastroesophageal reflux disease (GERD) diagnosed by a physician and requiring treatment (i.e., pharmacological and/or non-pharmacological treatments such as a wedge)
- Participant or parent/guardian unsuitable for the study, at the discretion of the investigator
- Sibling in the home is already enrolled in the study
Key Trial Info
Start Date :
April 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT04803981
Start Date
April 9 2021
End Date
July 1 2023
Last Update
April 13 2021
Active Locations (1)
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1
Duke Clinical Research Institute
Durham, North Carolina, United States, 27701